Menopausal and female climacteric states
Conditions
Interventions
Assessment tools:
1. Questionnaires applied:
• Sociodemographic clinical questionnaire: general sociodemographic characteristics, gynecological history and sleep related questions were questioned
• Kupperman Menopausal Index (KMI):
• Insomnia Severity Index (ISI)
• STOP-Bang questionnaire
• Beck Depression Inventory (BDI)
• Beck Anxiety Inventory (BAI)
• Hospital anxiety and depression scale (HADS)
• Menopausal Assessment Scale (MAS)
• Pittsburgh Sleep Quality Index (PSQI)
• Epworth Sleepiness Scale (ESE)
• Specific Quality of Life for Menopause (SQLM)
2. Clinical examination:
• If the volunteer went through hysterectomy and / or oophorectomy and, therefore, does not know if she is in post menopause, hormonal dosage evaluation test was performed.
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Other
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
48 Years to 65 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women between 48 and 65 years old; Hysterectomized and / or oophorectomized women with follicle stimulating hormone (FSH) concentrations 30 mUl / mL; They haven't used hormone therapy in the last 3 months; They haven't used sleep medications in the last month; Stop-Bang questionnaire with score <3; Clinical diagnosis of insomnia
Exclusion criteria
Exclusion criteria: Diagnosis of uncontrolled clinical diseases; History of serious neurological or psychiatric disorders; In treatment for insomnia or for complaints of postmenopausal symptoms; In drug treatment with the use of benzodiazepines, antihistamines, hypnotics, hypnotic phytotherapics, sedatives, antidepressants, antipsychotics, stimulants (amphetamine, caffeine, modafinil), corticosteroids; They have previously received aromatherapy treatment; They have been practice meditation or yoga for sleep problems; If they will presente repulsion to the odor of Lavandula angustifolia essential oil or sunflower oil; Workers in shift; Illiteracy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Sleep quality assessment using the Pittsburgh Sleep Quality Index, which was applied at the beginning and end of the intervention.;Outcome 1: The volunteers who inhaled the lavender essential oil and the volunteers who used the placebo had a significant improvement in sleep quality at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to count and compare the total sleep time in both moments.;Outcome 1: No difference in total sleep time was found in the comparison between groups and between the times;Expected outcome 2: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to count and compare the sleep onset latency in both moments;Outcome 2: No difference in sleep onset latency was found in the comparison between groups and between the times;Expected outcome 3: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to observe and compare sleep efficiency in both moments;Outcome 3: The aromatherapy intervention group had a significant increase in sleep efficiency after the intervention was completed;Expected outcome 4: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to observe and compare percentage of N1 sleep in both moments;Outcome 4: No difference in percentage of N1 sleep was found in the comparison between groups and between the times;Expected outcome 5: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to observe and compare percentage of N2 sleep in both moments;Outcome 5: No difference in percentage of N2 sleep was found in the comparison between groups and between the times;Expected outcome 6: Evaluation of the sleep pattern observed by the polysomnography exam that was performed at the beginning and end of the study. With this exam, it was possible to observe and compare percentage of N3 | — |
Countries
Brazil
Contacts
Public ContactLeandro;Leandro dos Lucena;Lucena
Universidade Federal de São Paulo;Universidade Federal de São Paulo
Outcome results
None listed